JP2018504368A - 中鎖トリグリセリドを含むてんかんの治療用の組成物及び方法 - Google Patents
中鎖トリグリセリドを含むてんかんの治療用の組成物及び方法 Download PDFInfo
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Abstract
Description
[0011]以下の略語を本明細書で使用する場合がある:MCT、中鎖トリグリセリド;AA、アラキドン酸;AED、抗てんかん薬;ALA、アルファ−リノレン酸;ANOVA、分散分析;DHA、ドコサヘキサエン酸;DPA、ドコサペンタエン酸;EPA、エイコサペンタエン酸;LA、リノール酸;LCPUFA、長鎖多価不飽和脂肪酸(本明細書中で使用される場合、LCPUFAは、1つ以上のこのような脂肪酸のことをいう);NO、一酸化窒素;NORC、一酸化窒素放出化合物(1種又は複数);及びL−Arg、L−アルギニン。
式中、R’、R’’及びR’’’は、グリセロール骨格にエステル化された炭素骨格に5〜12個の炭素を有する脂肪酸である。本発明のMCTは、直接エステル化、転位、分別、エステル交換などの、当該技術分野において知られている任意の方法によって調製することができる。例えば、MCTは、ココナッツ油などの植物油の転位によって調製することができる。鎖長の長さ及び分布は、供給源の油によって変わり得る。例えば、1〜10%のC6、30〜60%のC8、30〜60%のC10、1〜10%のC12を含有するMCTは、一般に、パーム油及びココナッツ油から誘導される。グリセリンに対するオクタン酸の半合成エステル化によって、R’、R’’及びR’’’において約95%を超えるC8を含有するMCTを製造することができる。また、約50%の総C8及び/又は約50%の総C10を有するMCTを含む混合物も本明細書において有用である。前述のMCT組成物については、商業的供給源を利用することができ、当業者に知られている。このようなMCTは同じように挙動し、本明細書で使用されるMCTという用語内に包含される。
[0039]本発明者らは、抗てんかん薬(AED)と共に中鎖トリグリセリド(MCT)を投与することにより、動物におけるてんかんの治療に相乗効果を提供することができることを発見した。また、本方法及び組成物は、伝統的ケトン食餌と比較して、イヌのてんかんの食餌管理のために、低割合のMCT及び高割合の食餌炭水化物を利用することができる。このように、本てんかん治療はケトン食餌を必要としないが、そのような食餌の使用は禁止されない。このような相乗作用は、MCTを有しない比較可能な食餌に対して測ることができる。一実施形態では、本投与は、MCTを含有しない食品組成物とのAEDの投与と比較して、動物の発作頻度を少なくとも50%低減させる。様々な実施形態において、そのような発作の減少は、少なくとも10%、20%、30%、40%、50%、60%、70%、80%、90%、又は1つの特定の態様では100%であり得る。
[0088]イヌのてんかんにおいてMCTを含有する食餌とMCTを含有しない標準化プラセボ食餌を比較する、6ヶ月の前向き無作為化二重盲検プラセボ対照交差食餌試験を行った。被験体にMCTとプラセボ食餌のいずれか一方を3ヶ月間(1日目〜90日目±2日)給餌し、その後それぞれ食餌を切り替えて更に3ヶ月間(90日目〜180日目±2日)給餌した。訪問1(2日目)、訪問2(90日目±2日)及び訪問3(180日目±2日)において次の変数について関連するデータを収集した:発作頻度;体重;必要に応じて血清フェノバルビタール(PB)及び/又は(臭化カリウム)KBrの濃度の測定値;動態的(dynamic)胆汁酸;全血球数;標準的な臨床血清化学;並びに有害事象。食餌の割り当ては無作為化され、食餌分配者でもあった研究看護師のみが利用可能であったため、研究の間ずっと、関与した飼い主、調査者及び統計者は盲検化された。
[0093]結果は、イヌが、プラセボ食餌(4.4/月、0.3〜22.9/月、p=0.0195;表1)と比較して、MCT(2.8/月、0〜10/月)を受けた場合、有意に低い発作頻度を示した。3匹のイヌは発作からの完全な解放を達成し(100%減少)、7匹のイヌは発作頻度が50%以上減少し(56.85%、50.76〜62.8%)、5匹のイヌは発作頻度が全般的に減少した(38.87%、35.68〜43.27%)。6匹のイヌはMCTに対して反応がなく、発作頻度の全般的な上昇を示した。
Claims (20)
- 動物における抗てんかん薬(AED)の効果を増強するのに適した食餌計画であって、前記AEDと、中鎖トリグリセリド(MCT)を含む食品組成物とを含み、前記MCTは、前記食品組成物及び前記AEDを前記動物に投与した場合に前記AEDの効果を増強するのに有効な量で前記食品組成物中に存在する、食餌計画。
- 前記動物が、ヒト又はコンパニオン動物である、請求項1に記載の食餌計画。
- 前記動物が、イヌ又はネコである、請求項1に記載の食餌計画。
- 前記R’、R’’、及びR’’’の約95%超が8個の炭素長さである、請求項5に記載の食餌計画。
- 残りのR’、R’’、及びR’’’が、6個の炭素又は10個の炭素の脂肪酸である、請求項6に記載の食餌計画。
- 前記食品組成物が、約1%〜約15%の前記MCTを含む、請求項1に記載の食餌計画。
- 前記AEDが、アセタゾラミド、カルバマゼピン、クロラゼペート、クロバザム、クロナゼパム、ジアゼパム、エスリカルバゼピンアセテート、エチシキスヌデム、エトスクシミド、フェルバメート、ガバペンチン、イメピトイン、ケプラ、ラコサミド、ラモトリジン、レベチラセタム、メチルフェノバルビトン、ニトラゼパム、オキシカルバゼピン、ペランパネル、ピラセタム、フェノバルビタール、フェニトイン、臭化カリウム、プレガバリン、プリミドン、レチガビン、ルフィナミド、臭化ナトリウム、バルプロ酸ナトリウム、スチリペントール、スルチアム、チアガビン、トピラメート、バルプロ酸、ビガバトリン、ゾニサミド、これらの塩、これらの誘導体、及びこれらの混合物からなる群から選択される、請求項1に記載の食餌計画。
- 前記食品組成物が、ヒト食品組成物、ペット食品組成物、又は食餌補助剤として処方される、請求項1に記載の食餌計画。
- 前記食品組成物が、約15%〜約50%のタンパク質、約5%〜約40%の脂肪、約5%〜約10%の灰分含有量を更に含み、約5%〜約20%の水分含有量を有する、請求項1に記載の食餌計画。
- 前記食品組成物が、前記AEDを含む、請求項1に記載の食餌計画。
- 動物における抗てんかん薬(AED)の効果を増強する方法であって、抗てんかん薬(AED)と共に中鎖トリグリセリド(MCT)を含む食品組成物を前記動物に投与する工程を含み、前記MCTは、前記動物における前記AEDの効果を増強するのに有効な量で投与される、方法。
- 前記動物が、ヒト又はコンパニオン動物である、請求項12に記載の方法。
- 前記動物が、イヌ又はネコである、請求項12に記載の方法。
- 前記MCTは、式1(式中、グリセロール骨格にエステル化されたR’、R’’、及びR’’’は、それぞれ独立して5〜12個の炭素を有する脂肪酸である。)のものであり、前記AEDは、アセタゾラミド、カルバマゼピン、クロラゼペート、クロバザム、クロナゼパム、ジアゼパム、エスリカルバゼピンアセテート、エチシキスヌデム、エトスクシミド、フェルバメート、ガバペンチン、イメピトイン、ケプラ、ラコサミド、ラモトリジン、レベチラセタム、メチルフェノバルビトン、ニトラゼパム、オキシカルバゼピン、ペランパネル、ピラセタム、フェノバルビタール、フェニトイン、臭化カリウム、プレガバリン、プリミドン、レチガビン、ルフィナミド、臭化ナトリウム、バルプロ酸ナトリウム、スチリペントール、スルチアム、チアガビン、トピラメート、バルプロ酸、ビガバトリン、ゾニサミド、これらの塩、これらの誘導体、及びこれらの混合物からなる群から選択される、請求項12に記載の方法。
- 前記食品組成物が、約1%〜約15%の前記MCTを含み、前記食品組成物が前記AEDと同時に投与される、請求項12に記載の方法。
- 前記食品組成物が、長期定期的に投与される、請求項12に記載の方法。
- 前記食品組成物が、毎日、前記動物に投与される、請求項12に記載の方法。
- 前記投与は、前記MCTを含有しない食品組成物を用いた前記AEDの投与と比較して、前記動物の発作頻度を少なくとも50%減少させる、請求項12に記載の方法。
- 動物における抗てんかん薬(AED)の効果を増強するための医薬組成物であって、中鎖トリグリセリド(MCT)と前記AEDとを含み、前記MCTは、前記医薬組成物を前記動物に投与した場合に前記AEDの効果を増強するのに有効な量で存在する、医薬組成物。
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